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dialysis products 24 articles

Fresenius fighting request to produce adverse event reports related to GranuFlo, NaturLyte

Fresenius Medical Care is fighting a request by plaintiffs for the dialysis products and services provider to produce hard copies of adverse event reports involving patients because it would require the company to sift through records at 2,100 clinics with a client base of 170,000 patients in 2013. The motion was filed in federal multidistrict litigation in Massachusetts alleging Fresenius withheld information that its dialysis concentrates GranuFlo and NaturaLyte could cause patients to suffer heart problems and deaths. GranuFlo and NaturaLyte are solutions used to maintain proper acid balance in patients’ blood when they undergo hemodialysis for the treatment of ... Read More

Fresenius may open new dialysis clinic in Louisiana despite AG’s lawsuit

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is proposing to build a new dialysis center in Terrytown, La., despite being slapped with a lawsuit by the state’s Attorney General earlier this month. Fresenius owns nearly 100 dialysis clinics in Louisiana. The company uses its brand-name products in its facilities and also sells them to non-Fresenius-owned clinics. The state’s lawsuit claims that Fresenius’s dialysis concentrates GranuFlo and NaturaLyte caused patients to suffer from injuries including sudden cardiac arrest, and that the company violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents by ... Read More

Injuries, death linked to recalled NaturaLyte dialysis concentrate

Fresenius Medical Care, the world’s largest provider of dialysis products and services, has received one report of death and two injuries linked to recalled lots of NaturaLyte liquid bicarbonate concentrate. The recall was initiated after testing revealed that certain lots of NaturaLyte had elevated levels of a bacteria identified as Halmonas, a Gram Negative bacteria typically found in water with high salinity. Bacterial contamination of dialysate could cause bacteremia or systemic infection. Fresenius issued a recall of 49 lots in on April 4, followed by a second recall of nine additional lots on May 1. At that time, Fresenius said that ... Read More

Fresenius faces another GranuFlo wrongful death lawsuit

A West Virginia man has filed a lawsuit against Fresenius Medical Care claiming a dialysis concentrate manufactured by the company caused his wife’s death. Fresenius is the world’s largest provider of dialysis products and services. There are more than 1,800 Fresenius facilities nationwide. The company’s products are also used in non-Fresenius-owned clinics. James Stockton alleges that for nearly 10 years his wife Beverly underwent dialysis treatment during which she received GranuFlo, a solution used to balance electrolytes in patents undergoing dialysis. GranuFlo contains an ingredient that metabolizes in the body to bicarbonate. Elevated levels of bicarbonate have been linked to heart ... Read More

Fresenius issues second recall of NaturaLyte due to bacterial contamination

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is recalling 56 lots of NaturaLyte Liquid Bicarbonate Concentrate, which is used in hemodialysis machines, because the dialysis concentrate may be contaminated with bacteria, which could lead to bacteremia or systemic infection in patients treated with affect products. Fresenius says that the dialysis filter, called a dialyzer, and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that reduces the likelihood of adverse events from occurring. The announcement follows a recall of 49 lots of NaturaLyte due to high levels of bacterial contamination ... Read More

Fresenius recalls 49 lots of NaturaLyte due to bacterial contamination

Fresenius Medical Care, the world’s largest distributor of dialysis products and services, is issuing an urgent medical device recall on 49 lots of NaturaLyte Liquid Bicarbonate Concentrate due to high levels of bacterial contamination found in the product. The company says it is currently conducting an investigation to identify the organism(s) in its dialysis concentrate and, when testing is complete, will announce the identity of those bacteria. NaturaLyte is used to regulate electrolytes in patients undergoing dialysis treatment. The company says no pyrogenic reactions, bacterial infections or related adverse events have been reported to date in connection with the recall. ... Read More

Recent actions call into question whether Fresenius cares about patient safety

Recent actions by Fresenius Medical Care suggest the world’s largest provider of dialysis products and services may not be too concerned about patient safety. One example is the case of Robert Hiller. In January, he filed a lawsuit against Fresenius alleging he was wrongfully fired for simply doing his job of putting “into effect the company’s manufacturing practices to ensure that they were safe and complied with federal and state laws.” He alleged that in 2010 he first raised concerns whether certain practices where harming the purity of some of the products, but Fresenius officials initially dismissed his concerns. He was ... Read More

Fresenius recalls defective dialysis machines

Fresenius Medical Care is recalling more than 111,000 hemodialysis machines sold throughout the United States, Canada and Mexico. The recall, which affects specific model numbers from the Fresenius 2008 Series hemodialysis machines, was issued due to complaints of the saline bags inappropriately filling during recirculation and setup. Dialysis machines are designed to cleanse and filter the blood of patients with kidney disease whose kidneys do not function properly. Nearly 400,000 people in the United States undergo this life-saving treatment every day. Fresenius is the world’s largest provider of dialysis products and services, providing dialysis treatments within its own facilities and ... Read More

Two more GranuFlo lawsuits filed against dialysis giant Fresenius

Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks. Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies. GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands. In March 2012, the ... Read More

Fresenius to open dialysis clinic in McCalla, Ala.

Fresenius Medical Care, the world’s largest provider of dialysis services and products, will open a dialysis clinic in McCalla, Ala. The facility is expected to be be in operation by May or June 2014. The property, located near McAdory High School, was purchased by Southeast Medical McCalla LLC. Construction on a one-story medical office building is expected to start sometime in October. Fresenius operates dialysis clinics throughout the country and provides dialysis products, such as dialysis concentrates GranuFlo and NaturaLyte, for both Fresenius-owned and non-Fresenius clinics. The company is facing numerous wrongful death, personal injury and false advertising lawsuits involving ... Read More